FDA.reportPublic FDA data

PMA P160054S006

Device
HeartMate 3™ Left Ventricular Assist System
Applicant
ABBOTT MEDICAL
PMA number
P160054
Supplement
S006
Product code
DSQ
Decision date
2018-05-31
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
Approval for updating the packaging materials for the existing Modular Cable Cap and Coring Knife standalone packaging configurations, and introducing a standalone packaging configuration for the Apical Cuff, Skin Coring Punch, Thread Protectors, and Tunneling Adapter.

Current openFDA PMA Record#

Device
HeartMate 3™ Left Ventricular Assist System
Applicant
ABBOTT MEDICAL
PMA number
P160054
Supplement
S006
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2018-05-31
Decision code
APPR
Date received
2018-04-12
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for updating the packaging materials for the existing Modular Cable Cap and Coring Knife standalone packaging configurations, and introducing a standalone packaging configuration for the Apical Cuff, Skin Coring Punch, Thread Protectors, and Tunneling Adapter.